利用虹膜扫描技术对刚果民主共和国埃博拉疫苗试验中健康成年人进行生物识别：混合方法研究。
Use of Iris Scanning for Biometric Recognition of Healthy Adults Participating in an Ebola Vaccine Trial in the Democratic Republic of the Congo: Mixed Methods Study.
机构信息
Department of Tropical Medicine, University of Kinshasa, Kinshasa, the Democratic Republic of the Congo.
Global Health Institute, University of Antwerp, Antwerp, Belgium.
出版信息
J Med Internet Res. 2021 Aug 9;23(8):e28573. doi: 10.2196/28573.
BACKGROUND
A partnership between the University of Antwerp and the University of Kinshasa implemented the EBOVAC3 clinical trial with an Ebola vaccine regimen administered to health care provider participants in Tshuapa Province, Democratic Republic of the Congo. This randomized controlled trial was part of an Ebola outbreak preparedness initiative financed through Innovative Medicines Initiative-European Union. The EBOVAC3 clinical trial used iris scan technology to identify all health care provider participants enrolled in the vaccine trial, to ensure that the right participant received the right vaccine at the right visit.
OBJECTIVE
We aimed to assess the acceptability, accuracy, and feasibility of iris scan technology as an identification method within a population of health care provider participants in a vaccine trial in a remote setting.
METHODS
We used a mixed methods study. The acceptability was assessed prior to the trial through 12 focus group discussions (FGDs) and was assessed at enrollment. Feasibility and accuracy research was conducted using a longitudinal trial study design, where iris scanning was compared with the unique study ID card to identify health care provider participants at enrollment and at their follow-up visits.
RESULTS
During the FGDs, health care provider participants were mainly concerned about the iris scan technology causing physical problems to their eyes or exposing them to spiritual problems through sorcery. However, 99% (85/86; 95% CI 97.1-100.0) of health care provider participants in the FGDs agreed to be identified by the iris scan. Also, at enrollment, 99.0% (692/699; 95% CI 98.2-99.7) of health care provider participants accepted to be identified by iris scan. Iris scan technology correctly identified 93.1% (636/683; 95% CI 91.2-95.0) of the participants returning for scheduled follow-up visits. The iris scanning operation lasted 2 minutes or less for 96.0% (656/683; 95% CI 94.6-97.5), and 1 attempt was enough to identify the majority of study participants (475/683, 69.5%; 95% CI 66.1-73.0).
CONCLUSIONS
Iris scans are highly acceptable as an identification tool in a clinical trial for health care provider participants in a remote setting. Its operationalization during the trial demonstrated a high level of accuracy that can reliably identify individuals. Iris scanning is found to be feasible in clinical trials but requires a trained operator to reduce the duration and the number of attempts to identify a participant.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04186000; https://clinicaltrials.gov/ct2/show/NCT04186000.
背景
安特卫普大学和金沙萨大学之间的合作伙伴关系在刚果民主共和国的 Tshuapa 省实施了 EBOVAC3 临床试验，该试验为卫生保健提供者参与者提供了埃博拉疫苗方案。这项随机对照试验是通过创新药物倡议-欧盟资助的埃博拉疫情防范倡议的一部分。EBOVAC3 临床试验使用虹膜扫描技术来识别疫苗试验中所有登记的卫生保健提供者参与者，以确保正确的参与者在正确的访问中接受正确的疫苗。
目的
我们旨在评估在偏远地区的疫苗试验中，作为一种人群健康保健提供者参与者识别方法的虹膜扫描技术的可接受性、准确性和可行性。
方法
我们采用混合方法研究。通过 12 次焦点小组讨论（FGD）在试验前评估可接受性，并在登记时进行评估。使用纵向试验研究设计进行可行性和准确性研究，在登记和随访时将虹膜扫描与独特的研究 ID 卡进行比较，以识别卫生保健提供者参与者。
结果
在 FGD 期间，卫生保健提供者参与者主要担心虹膜扫描技术会对他们的眼睛造成身体问题，或者通过巫术使他们暴露于精神问题。然而，99%（85/86；95%CI 97.1-100.0）的 FGD 卫生保健提供者参与者同意通过虹膜扫描进行识别。此外，在登记时，99.0%（692/699；95%CI 98.2-99.7）的卫生保健提供者参与者接受通过虹膜扫描进行识别。虹膜扫描技术正确识别了 93.1%（636/683；95%CI 91.2-95.0）返回计划随访的参与者。96.0%（656/683；95%CI 94.6-97.5）的参与者虹膜扫描操作持续 2 分钟或更短时间，且 1 次尝试足以识别大多数研究参与者（475/683，69.5%；95%CI 66.1-73.0）。
结论
在偏远地区的卫生保健提供者参与者的临床试验中，虹膜扫描作为一种识别工具具有很高的可接受性。其在试验中的运作表明了其高度的准确性，能够可靠地识别个人。虹膜扫描在临床试验中是可行的，但需要经过培训的操作员来减少识别参与者的时间和次数。
试验注册
ClinicalTrials.gov NCT04186000；https://clinicaltrials.gov/ct2/show/NCT04186000。
Zotero 插件